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Tuesday, October 23, 2007
P3-37

GUIDANCE FOR INCORPORATING ETHICAL, LEGAL, AND SOCIAL ISSUES INTO HEALTH TECHNOLOGY ASSESSMENTS IN GENETIC SCREENING: AN ENVIRONMENTAL SCAN

Beth K. Potter1, Brenda J. Wilson1, Denise Avard2, Timothy Caulfield3, Pranesh Chakraborty4, Vikki Entwistle5, Ian Graham6, Glenn Griener3, Christine Kennedy7, Marissa McGuire1, Mark Montgomery8, and George Wells9. (1) University of Ottawa, Ottawa, ON, Canada, (2) University of Montreal, Montreal, QC, Canada, (3) University of Alberta, Edmonton, AB, Canada, (4) Children's Hospital of Eastern Ontario, Ottawa, ON, Canada, (5) University of Dundee, Dundee, United Kingdom, (6) Canadian Institutes of Health Research, Ottawa, ON, Canada, (7) Queen's University, Kingston, ON, Canada, (8) University of Calgary, Calgary, AB, Canada, (9) Ottawa Heart Institute, Ottawa, ON, Canada

Background: To what degree should policy-oriented evaluation research, such as health technology assessment (HTA), consider ethical, legal, and social issues (“ELSIs”)? Addressing ELSIs in HTA poses a number of challenges related to the nature of ELSI evidence, how it can be identified and summarized, and how it can be integrated with clinical evidence, particularly given its dependence on the cultural and health system context. These ideas may be most salient to technologies that have been viewed as ethically complex, such as genetic screening.

Methods: We used an environmental scan of three bodies of literature to review recommendations for incorporating ELSIs into HTA with an emphasis on genetic screening. From the HTA literature, we identified general guidance for incorporating ELSIs in HTA. From the disease screening and public health genomics literatures, we searched for frameworks developed to guide policy decisions, identifying how ELSIs were explicitly or implicitly considered.

Results: In the HTA literature we found widespread recognition of the importance of integrating ELSIs into HTA. The few practical methods we identified fell within three broad categories: 1) Identifying and considering ELSIs through a literature synthesis component of HTA; 2) Addressing ELSIs through direct involvement or consultation with ELSI experts (e.g., experts in bioethics, health law, or sociology); and 3) Considering ELSIs by incorporating the views or values of stakeholders.

In the disease screening and public health genomics literatures we identified 12 evaluation frameworks. These included frameworks based on traditional disease-screening criteria or on systematic review methods for evaluating screening programs, and frameworks developed to support policy decisions regarding genetic tests. When reviewing how ELSIs were considered in these frameworks, we identified the same three broad approaches listed above as well as an emphasis on particular ELSIs relevant to these technologies.

Conclusions: Findings from the HTA, disease screening, and public health genomics literatures suggest that the method of addressing ELSIs in HTA for genetic screening may determine which particular ELSIs are prioritized. Systematic review methods tend to emphasize ELSIs that can be empirically evaluated (e.g., psychosocial impacts of screening), while those that involve ethical analysis or soliciting stakeholder views may emphasize broader ELSIs (e.g., the acceptability of pregnancy termination). An overall important challenge is the lack of clear guidance for evaluating approaches to addressing ELSIs in HTA.


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See more of The 29th Annual Meeting of the Society for Medical Decision Making (October 20-24, 2007)